What the FTC’s Rule Banning Non-Competes Means for Healthcare

The FTC unveiled its long-awaited final rule banning most non-compete agreements during a live broadcast of a Commission meeting on April 23, 2024. The proposed rule, which was first announced in January 2023, underwent an extensive public comment process in which approximately 26,000 comments were received. According to the FTC, approximately 25,000 of these comments supported a total ban on non-competes. While there was some expectation that the final rule would be less aggressive than the proposed rule, that turned out not to be the case. By late summer 2024, most employers, except for non-profit organizations, will not be able to enforce or obtain non-competes in the U.S. except in extremely narrow circumstances. The new rule will take effect 120 days after it is published in the Federal Register. Assuming the rule is published this week, we can expect it to take effect by late August. That is, of course, if a court does not enjoin the rule first. Shortly after the rule was announced on April 23, the U.S. Chamber of Commerce stated its intention to sue the FTC. U.S. Chamber to Sue FTC Over Unlawful Power Grab on Noncompete Agreements Ban | U.S. Chamber of Commerce (uschamber.com) The first lawsuit challenging the new rule was filed on April 23, Ryan, LLC v. Federal Trade Commission, Case No. 3:24cv986 (N.D. Tex. Apr. 23, 2024). Among other relief, the Ryan suit seeks to have the rule vacated and set aside. There are significant legal questions concerning whether the FTC has the authority to take this action by rulemaking or whether this is best left to the legislative process. While some U.S. states have banned non-competes, many U.S. states have not banned them.

As written, the rule will have profound effects on virtually every industry, especially health care, where non-competes are common in physician and mid-level practitioner employment agreements. As several Commissioners indicated during the April 23 meeting, they are particularly concerned about non-competes in health care and believe this rule will save approximately $74-194 billion in reduced spending on physician services over the next decade.

Following is Nelson Mullins’ quick take on what health care employers need to know:

  1. The rule does not apply to non-profits. The basis for the rule making is Section 5 of the FTC Act, which doesn’t apply to non-profits. So, a non-profit health system that has non-competes with physicians or other workers is not impacted by the rule. Be aware, though, that the FTC may be looking to test whether some non-profit health systems are really operating as true non-profits. Tax exempt status alone will not be enough. We believe, however, that given significant and quantifiable charitable benefits that most non-profit systems provide, the FTC may be hard pressed to find a good test case within the non-profit health care industry.
  2. For all others, the rule bans all non-compete agreements for any worker, regardless of title, job function, or compensation, after the effective date. Thus, a for-profit health system or for-profit physician practice that uses non-competes will be significantly limited. The only non-competes that will be allowed to remain in force are non-competes for “Senior Executives” that were entered into before the rule becomes effective.
  3. The rule will take effect 120 days after it is published in the Federal Register. This will likely occur this week, so we expect the effective date to be approximately August 20, 2024.
  4. The rule rescinds existing non-competes for all workers who are not “Senior Executives.”
  5. “Senior Executive” is a narrowly-defined term meaning:
    1. a person in a policy making position; and
    2. who was paid at least $151,164 in the prior year.
  6. Existing non-competes for Senior Executives are not rescinded. New non-competes with Senior Executives entered into prior to the effective date are still allowed. However, no new non-competes with Senior Executives may be entered into after the effective date.
  7. “Policy-making position” means: President, CEO, or equivalent, or other person who has policy making authority, i.e., decisions that control a significant aspect of a business entity. Most clinicians will not meet the definition of “Senior Executive.”
  8. Non-senior executives who are now under a non-compete must be given notice by the effective date that their non-compete will not be, and cannot legally be, enforced. Model language for the notice is in the rule.
For more news on the Implications of the FTC Noncompete Ban on Healthcare, visit the NLR Health Law & Managed Care section.

How Lawyers Can Effectively Leverage Their Published Articles

Writing and publishing articles or blog posts can be a powerful branding and business development tool for lawyers. Not only do they demonstrate your expertise in your practice area, but they also significantly enhance your visibility and credibility.

However, your work doesn’t end once the article is published – in fact, it’s just beginning. Here are some tips to maximize the value, reach and impact of your published work.

1. Optimize for Online Search First and foremost, ensure your article is search engine optimized (SEO). This means incorporating relevant keywords that potential clients might use to find information related to your legal expertise. SEO increases the visibility of your content on search engines like Google, making it easier for your target audience to find you.

2. Share on Social Media Utilize your personal and professional social media platforms to share your article. LinkedIn, Twitter and even Facebook are excellent venues for reaching other professionals and potential clients. Don’t just share it once; periodically repost it, especially if the topic is evergreen. Engage with comments and discussions to further boost your post’s visibility.

3. Incorporate Into Newsletters If you or your firm sends out a regular newsletter, include a link to your article. This not only provides added value to your subscribers but also keeps your existing client base engaged with your latest insights and activities. This approach can help reinforce your position as a thought leader in your field. Also, consider launching a LinkedIn newsletter. LinkedIn’s platform offers a unique opportunity to reach a professional audience directly, increasing the potential for networking and attracting new clients who are actively interested in your area of expertise.

4. Speak at Conferences and Seminars Use your article as a springboard to secure speaking engagements. Conferences, seminars and panel discussions often look for experts who can contribute interesting insights. Your article can serve as a proof of your expertise and a teaser of your presentation content, making you an attractive candidate for these events.

5. Create Multimedia Versions Expand the reach of your article by adapting it into different formats. Consider recording a podcast episode discussing the topic in depth, or creating a short-form video for LinkedIn and YouTube. These formats can attract different segments of your audience and make the content more accessible.

6. Network Through Professional Groups Share your article in professional groups and online forums in your field, as well as alumni groups (law school, undergrad school and former firms). This can lead to discussions with peers and can even attract referrals. Active participation in these groups, coupled with sharing insightful content, can significantly expand your professional network.

7. Use as a Teaching Resource Offer to guest lecture at local law schools and use your article as a teaching resource. This not only enhances your reputation as an expert but also builds relationships with the upcoming generation of lawyers who could become colleagues or refer clients in the future.

8. Repurpose Content for Blogs or Articles Break down the article into smaller blog posts or develop certain points further into new articles. This can help maintain a consistent stream of content on your website, which is good for SEO and keeps your audience engaged over time.

9. Monitor and Engage with Feedback Keep an eye on comments and feedback from your article across all platforms. Engaging with readers can provide insights into what your audience finds useful, shaping your future writing to better meet their needs. It also helps in building a loyal following.

10. Track Metrics Utilize analytics tools (web, social media and email) to track how well your article performs in terms of views, shares and engagement. This data can help you understand what works and what doesn’t, guiding your content strategy for future articles.

11. Leverage the Power of Content Repurposing Content repurposing can significantly extend the life and reach of your original article. By transforming the article into different content formats—such as infographics, webinars, slide decks or even e-books—you cater to various learning styles and preferences, reaching a broader audience. This strategy not only maximizes your content’s exposure but also enhances engagement by presenting the information in new, accessible ways. Repurposing content can help solidify your reputation as a versatile and resourceful expert in your field.

Publishing an article or blog post is just the beginning. By strategically promoting and leveraging your published works, you can enhance your visibility, establish yourself as a thought leader and attract more clients. Every article has the potential to open new doors; it’s up to you to make sure it does!

U.S. EPA Finalizes Designation of Two PFAS Chemicals as Hazardous Substances Under CERCLA

On April 19, the U.S. Environmental Protection Agency (EPA) released its long-awaited final rule designating perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, as “hazardous substances” under Section 102(a) of the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA” or “Superfund”) (the “Final Rule”). The designation, which takes effect 60 days after the final rule is published in the Federal Register, will provide expanded investigation and remediation authority to EPA, will provide a powerful tool for private actions under CERCLA, and will trigger additional release reporting requirements. It will also expand enforcement authority in states that regulate CERCLA-designated hazardous substances.

Hazardous Substance Designation of PFOA and PFOS Has Broad Implications for Cleanups and CERCLA Liability

PFOA and PFOS are two specific chemical compounds within a broad group of thousands of manmade chemicals known as per- and polyfluoroalkyl substances (PFAS). EPA focused its regulatory efforts on these two PFAS; however, the vast majority of PFAS remain unregulated under CERCLA even after issuance of the Final Rule.

Designating PFOA and PFOS as hazardous substances triggers numerous requirements. The primary impact of the Final Rule is that it incorporates PFOS and PFOA into CERCLA’s strict, joint and several liability framework. This change grants EPA the power to investigate releases of PFOA and PFOS and compel potentially responsible parties (PRPs), including owners and operators of a property or facility, to remediate releases of PFOA and PFOS through the specific CERCLA enforcement provisions. PRPs also now have a clear private right of action under CERCLA to pursue cost recovery and contribution actions. Additionally, when the Final Rule becomes effective, facilities will be required to immediately report releases of PFOA and PFOS above their designated “reportable quantities,” (currently one pound within a 24-hour period), to the National Response Center and relevant state or tribal authorities.

Furthermore, many states include CERCLA hazardous substances under their cleanup statutes, meaning these states will now be able to require remediation of PFOA and PFOS under state law.

Listing PFOA and PFOS as “hazardous substances” under CERCLA does not make PFOA or PFOS contaminated waste a “hazardous waste” or a “hazardous constituent” under the Resource Conservation and Recovery Act. However, this designation does require the U.S. Department of Transportation to designate PFOA and PFOS as “hazardous materials” for purposes of transport under the Hazardous Materials Regulations.

While the PFOA and PFOS CERCLA Listing is Final, Questions Remain

As noted in our prior article on the proposed rule, EPA’s designation of PFOA and PFOS as “hazardous substances” leaves several questions unanswered.

  • How will EPA’s CERCLA enforcement discretion policy really play out in practice? 

    Concurrently with the publication of the Final Rule, EPA also released a PFAS Enforcement Discretion and Settlement Policy under CERCLA. This enforcement policy captures EPA’s current position that it does not intend to pursue PRPs under circumstances where “equitable factors” do not support doing so. Enumerated circumstances in the policy include so-called “passive receivers” of PFAS, including community water systems and publicly-owned treatment works, publicly-owned municipal solid waste landfills, publicly-owned airports and local fire departments, and farms where PFAS-containing biosolids are applied to the land. However, EPA’s enforcement policy—which is not binding upon the agency and is subject to change at any time—should be viewed with a healthy dose of skepticism among regulated industries, considering the sheer breadth of potential CERCLA liability for these substances, as well as continued Congressional proposals to codify exemptions for passive receivers within the CERCLA statute itself. Notably, the agency’s enforcement position does not in any way prevent private parties from initiating cost recovery or contribution actions under CERCLA.

  • How will regulated industries manage the costs of PFOA and PFOS cleanup?PFAS contamination can be wide-ranging due to several factors unique to the chemicals themselves. Further, unlike remediation technologies for other well-studied contaminants, existing remediation technologies for PFOA and PFOS are nascent at best and are expensive at a large scale. It is therefore often difficult to even estimate accurate cost ranges for PFOA and PFOS cleanups, but costs can easily run into the millions of dollars at complex sites. Although EPA has published interim guidance on PFOA and PFOS disposal methods, and the recently passed Infrastructure Investment and Jobs Act provides $3.5 billion over five years for Superfund cleanups, the methods and money may not go as far as planned if cleanup costs for PFOA and PFOS sites end up exponentially higher.
  • How will EPA handle potential PFOA and PFOS contamination at closed Superfund sites?In response to comments seeking clarification on whether designating PFOA and PFOS will lead to the reopening of closed Superfund sites, EPA stated that the final rule “has no impact” on EPA’s authority to list PFOA and PFOS sites as Superfund sites. EPA’s question-and-answers page—which we note is not a binding statement from the agency—also states that “[d]esignation will not change EPA’s process for listing and/or deleting [National Priorities List (NPL)] sites or evaluating remedies’ protectiveness through five-year reviews, and it will not require PFOA and PFOS sampling at NPL (final or deleted) sites.” While the final rule does not require PFOA and PFOS sampling at closed sites, it does not prevent EPA from ordering sampling at these sites. PRPs who may have long ago stopped budgeting for remedial costs at existing or legacy locations that were remediated years and even decades ago, may find that they are required to revisit these sites where PFOA and PFOS may be present.
  • What cleanup standards will govern PFOA and PFOS remediation?There is a current patchwork of state regulatory standards relating to PFAS, ranging from binding cleanup levels, advisory guidance, or no PFAS standards at all, which may lead to similarly patchwork cleanup standards depending on which standards are applied as an appropriate “applicable or relevant and appropriate requirement” (ARAR) at a specific site. In addition, on April 10, 2024, EPA issued a final rule setting Maximum Contaminant Levels (MCL) for PFOA and PFOS in drinking water at 4.0 parts per trillion (ppt), individually. While these drinking water standards are separate from EPA’s final rule listing PFOA and PFOS as “hazardous substances” under CERCLA, the “hazardous substances” rule notes that the MCL may be an appropriate ARAR for cleanup efforts under CERCLA.
  • What other PFAS will EPA next target under CERCLA?As noted above, PFOA and PFOS are two specific PFAS among thousands of others currently and historically used. Much of the science on the potential health effects of PFAS (both individual chemical compounds and as a class) continues to evolve. In the meantime, EPA has moved to regulate additional types of PFAS under other statutes. For example, as we noted in a previous client alert, EPA recently published a proposed rule listing seven other PFAS compounds as hazardous constituents under RCRA. Some or all of these PFAS may eventually be targets of future CERCLA rulemaking efforts.

Next Steps

The Final Rule will take effect 60 days after it is published in the Federal Register. Affected parties should consider their portfolio of planned, active, and in some cases, closed remediation sites for potential implications, and companies may consider reviewing and updating their hazardous substance reporting and transportation protocols to address PFOA and PFOS as applicable.

FTC Approves Non-Compete Ban

On Tuesday afternoon, April 23, the Federal Trade Commission (FTC) voted 3-2 along party lines to approve its new rule on non-competes. The new rule, which will take effect in 120 days, essentially bans non-competes for all workers, finding them “an unfair method of competition – and therefore a violation of Section 5 of the FTC Act.”

Notably, a non-complete clause is broadly defined as a “contractual term or workplace policy that prohibits a worker from, penalizes a worker for, or functions to prevent a worker from seeking or accepting work in the United States with a different person where such work would begin after the conclusion of the employment or operating a business in the United States after the conclusion of the employment.”

The new rule applies retroactively to prior agreements, other than those for senior executives earning more than $151,164 a year in a “policy-making position.” Employers must provide notice to other workers subject to non-compete agreements that they are no longer enforceable.

Not limited to employees, the non-compete ban extends to independent contractors, externs, interns, volunteers, apprentices, and sole proprietors who provide a service to a person. It does not include non-competes entered into pursuant to a bona fide sale of a business entity or in a franchisor-franchisee relationship.

While the rule is final, expect legal challenges to follow. For example, the U.S. Chamber of Commerce, the nation’s largest business lobby, told reporters it plans to sue over the rule, claiming the FTC is not authorized to make this rule, that non-competes are not categorically unfair, and the rule is arbitrary. The Chamber’s thoughts were echoed by the opposing Republican FTC voters, who cited concerns about the FTC’s authority (as compared to the merits of such a rule).

While employers’ protectable interests are often a concern, it is important to note that this rule does not ban non-disclosure and confidentiality agreements.

“…it is an unfair method of competition – and therefore a violation of Section 5 of the FTC Act – for employers to enter into noncompetes with workers after the effective date.”
For more news on FTC’s noncompete ban, visit the NLR Labor & Employment section.

Final Rule Raises Salary Threshold to $58,656 for Employee Overtime Exemptions

The U.S. Department of Labor (DOL) has released a final rule that increases the salary threshold for the white collar overtime exemptions from the current $35,568 yearly minimum to $43,888 on July 1, 2024, and then to $58,656 on January 1, 2025. This means that, beginning January 1, 2025, most employees making less than $58,656 must receive overtime pay—time and a half their regular hourly rate—for any time worked more than 40 hours in one workweek. The changes also raise the salary requirement for what is known as the “highly compensated individual exemption” from the current $107,432 per year to $132,964 on July 1, 2024, and then to $151,164 on January 1, 2025. Notably, the DOL final rule requires automatic updates to the salary threshold every three years.

The DOL initially proposed to raise the overtime exemption to $55,068 and the salary requirement for the “highly compensated individual exemption” to $143,988. The final rule modifies those numbers and now involves incremental increases in a two-step process.

The DOL estimates that this impacts almost 4 million workers who are currently salaried. Employers must face the decision to either increase salaries for many exempt workers to the proposed minimum of $43,888 by July 1, 2024 and then $58,656 by January 1, 2025, or convert those exempt employees falling under the minimum salary to non-exempt hourly workers.

This rule will likely be challenged in the courts. However, it is uncertain whether these challenges will be successful. Therefore, businesses should take steps now to prepare:

  1. Review current exempt employees who earn between $35,568 and $55,656 per year. You can track employees’ actual hours worked now to learn the potential impact of converting them to overtime pay.
  2. Review current compliance. Although the proposed rule changes the salary threshold but not the other factors for an employee to be eligible for the “white collar” federal overtime exemption, the rule may cause employees to scrutinize their exempt classification. Employers should ensure that their exempt employees meet the three exception requirements: (1) paid on a salary basis; (2) paid at least the designated minimum salary; and (3) perform certain duties (which vary based on the exemption.)
  3. Plan to give advance notice to employees and provide training to managers and those workers impacted. If converted to non-exempt status, employees will need to be trained in record keeping requirements, timekeeping procedures, overtime approval policies, and other specifics that may vary from business to business.
For more news on the DOL’s Overtime Salary Threshold, visit the NLR Labor & Employment section.

EPA Designates Two PFAS as Hazardous Substances

On April 19, 2024, the U.S. Environmental Protection Agency (EPA) announced that it was designating two common per- and polyfluoroalkyl substances (PFAS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), commonly known as Superfund. As expected, EPA is issuing a final rule to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as hazardous substances. The pre-publication version of the rule is available here.

Once the rule is effective, entities will be required to report releases of PFOA and PFOS into the environment that meet or exceed the reportable quantity. Reporting past releases is not required if the releases have ceased as of the effective date of the rule. EPA will have the authority to order potentially responsible parties to test, remediate, or pay for the cleanup of sites contaminated with PFOA or PFOS under CERCLA.

Massachusetts established reportable concentrations for six PFAS, including PFOA and PFOS, in 2019. The Massachusetts regulations also contain cleanup standards for PFAS contamination in soil and groundwater.

Under Maine law, these substances also are automatically deemed a Maine hazardous substance regulated under the Maine Uncontrolled Hazardous Substance Sites Law. Maine’s PFAS screening levels are available here.

Solid waste facility operators had expressed serious concerns about the prospect of PFOA and PFOS being listed as hazardous substances under CERCLA and have advocated for a narrow exemption. Landfills can be recipients of PFAS-containing waste without knowing it. Similarly, wastewater treatment plant operators feared liability and increased costs if the rule designating PFOA and PFOS as hazardous substances became final.

EPA’s announcement of the final rule came with a CERCLA enforcement discretion policy [PFAS Enforcement Discretion and Settlement Policy Under CERCLA] that makes clear that EPA will focus enforcement on parties that significantly contributed to the release of PFAS into the environment.

The policy states that the EPA does not intend to pursue certain publicly‑owned facilities such as solid waste landfills, wastewater treatment plants, airports, and local fire departments, as well as farms where biosolids are applied to the land. Firefighting foam (aqueous film-forming foam, or AFFF) is known to contain PFAS, and runoff from the use of AFFF has been known to migrate into soil and groundwater.

FTC Issues Report to Congress Highlighting Collaboration with State Attorneys General

On April 10, 2024, the Federal Trade Commission issued a report to Congress on the agency’s collaboration with state attorneys general highlighting current cooperative law enforcement efforts, best practices to ensure continued collaboration and legislative recommendations to enhance such efforts.

The report, directed by the FTC Collaboration Act of 2021, “Working Together to Protect Consumers: A Study and Recommendations on FTC Collaboration with the State Attorneys General” makes legislative recommendations that would enhance these efforts, including reinstating the Commission’s authority to seek money for defrauded consumers and providing it with the independent authority to seek civil penalties.

“Today’s consumer protection challenges require an all-hands-on-deck response, and our report details how the FTC is working closely with state enforcers to share information, stop fraud, and ensure fairness in the marketplace,” said FTC attorney Samuel Levine, Director of the Bureau of Consumer Protection. “We look forward to seeking new opportunities to strengthen these ties and confront the challenges of the future.”

In June 2023, the Commission announced a request for public information (RFI) seeking public comments and suggestions on ways it can work more effectively with state AGs to help educate consumers about, and protect them from, potential fraud. After reviewing and analyzing the comments received, the agency developed the report to Congress issued today. The report is divided into three sections: 1) The FTC’s Existing Collaborative Efforts with State
Attorneys General to Prevent, Publicize, and Penalize Frauds and Scams; 2) Recommended Best Practices to Enhance Collaboration; and 3) Legislative Recommendations to Enhance Collaboration Efforts.

The first section lays out the roles and responsibilities of the FTC and state AGs in protecting consumers from frauds and scams, provides an overview of their respective law enforcement authority, and discusses how federal and state enforcers share their information and expertise to facilitate effective communication and cooperation. It also provides a breakdown of the FTC’s
structure and a description of the Consumer Sentinel consumer complaint database, the largest such information-sharing network in the United States.

The second section details best practices used to enhance strong information-sharing between the FTC and its state law enforcement partners, discusses how the Commission coordinates joint and parallel enforcement actions with state AGs and other state consumer protection agencies, and presents ideas on expanding the sharing of expertise and technical resources between agencies.

Finally, the third section stresses the legislative need to restore the FTC’s Section 13(b) authority to seek equitable monetary refunds for injured consumers, presents ways to enhance collaboration and conserve resources by providing the FTC with the independent authority to seek civil penalties, and describes the agency’s need for clear authority to pursue legal actions against those who assist and facilitate unfair or deceptive acts or practices.

The Commission vote approving the report to Congress was 3-0-2, with Commissioners Melissa Holyoak and Andrew N. Ferguson not participating. Chair Lina M. Khan issued a separate statement, in which she was joined by Commissioners Rebecca Kelly Slaughter and Alvaro M. Bedoya. Commissioner Slaughter also issued a separate statement.

U.S. Supreme Court: Forced Transfers of Employees Without Loss of Pay or Rank Violate Title VII

Federal law prohibits employers from relying on certain protected statuses (race, color, religion, sex, or national origin) when making employment decisions. Lower courts have required employees suing employers to point to a materially adverse harm caused by the alleged employer discrimination. But is a forced transfer of an employee to another department—with no loss of pay or rank—an “adverse employment” decision? On April 17, 2024, the U.S. Supreme Court ruled 9-0 in the affirmative.

In Muldrow v. City of St. Louis, a female police sergeant alleged she was transferred from one job to another because she is a woman, in violation of Title VII. While her rank and pay remained the same in the new position, her responsibilities (moving from being a plainclothes intelligence officer to a more administrative role), perks (e.g., no longer having a take-home car), and schedule (fewer weekends off) did not. The District Court reiterated Title VII’s prohibition against basing employment decisions on a person’s gender, but further opined that because the female police sergeant did not demonstrate there was a “significant” change in working conditions producing “material employment disadvantage,” her discrimination claim failed as a matter of law. The District Court reached this conclusion because she suffered no “change in salary or rank,” and therefore, there was no harm and no foul. The U.S. Court of Appeals for the Eighth Circuit agreed, concluding that the plaintiff did not have a viable employment discrimination claim because her job transfer “did not result in a diminution to her title, salary, or benefits.”

Writing for a unanimous court, Justice Elena Kagan reversed the Eighth Circuit, ruling that an employee need not show “significant, serious” or “material” change in employment conditions to maintain a discrimination claim “because the text of Title VII imposes no such requirement.” More specifically, the Supreme Court reasoned that there is nothing in Title VII that distinguishes “between transfers causing significant disadvantages and transfers causing not-so-significant ones.” All a plaintiff need show in a forced discriminatory transfer case is that the transfer left the employee “worse off,” but not “significantly worse” as numerous federal appellate decisions have previously held.

For All Patent/Trademark Practitioners: USPTO Provides Guidance for Use of AI in Preparing USPTO Submissions

The USPTO expounds a clear message for patent and trademark attorneys, patent agents, and inventors: use of artificial intelligence (AI), including generative AI, in patent and trademark activities and filings before the USPTO entails risks to be mitigated, and you must disclose use of AI in creation of an invention or practice before the USPTO if the use of AI is material to patentability.

The USPTO’s new guidance issued on April 11, 2024 is a counterpart to its guidance issued on February 13, 2024, which addresses AI-assisted invention creation process. In the new guidance issued on April 11, 2024, USPTO officials communicate the risks of using AI in preparing USPTO submissions, including patent applications, affidavits, petitions, office action responses, information disclosure statements, Patent Trial and Appeal Board (PTAB) submissions, and trademark / Trademark Trial and Appeal Board (TTAB) submissions. The common theme between the February 13 and April 11 guidance is the duty to disclose to the USPTO all information known to be material to patentability.

Building on the USPTO’s existing rules and policies, the USPTO’s April 11 guidance discusses the following:

(A) The duty of candor and good faith – each individual associated with a proceeding at the USPTO owes the duty to disclose the USPTO all information known to be material to patentability, including on the use of AI by inventors, parties, and practitioners.

(B) Signature requirement and corresponding certifications – using AI to draft documents without verifying information risks “critical misstatements and omissions”. Any submission for the USPTO in which AI helped prepare must be carefully reviewed by practitioners, who are ultimately responsible, to ensure that they are true and submitted for a proper purpose.

(C) Confidentiality of information – sensitive and confidential client information risks being compromised if shared to third-party AI systems, some of which may be located outside of the United States.

(D) Foreign filing licenses and export regulations – a foreign filing license from the USPTO does not authorize the exporting of subject matter abroad for the preparation of patent applications to be filed in the United States. Practitioners must ensure data is not improperly exported when using AI.

(E) USPTO electronic systems’ policies – Practitioners using AI must be mindful of the terms and conditions for the USPTO’s electronic system, which prohibit the unauthorized access, actions, use, modifications, or disclosure of the data contained in the USPTO system in transit to/from the system.

(F) The USPTO Rules of Professional Conduct – when using the AI tools, practitioners must ensure that they are not violating the duties owed to clients. For example, practitioners must have the requisite legal, scientific, and technical knowledge to reasonably represent the client, without inappropriate reliance on AI. Practitioners also have duty to reasonably consult with the client, including about the use of AI in accomplishing the client’s objectives.

The USPTO’s April 11 guidance overall shares principles with the ethics guidelines that multiple state bars have issued related to generative AI use in practice of law, and addresses them in the patent- and trademark-specific context. Importantly, in addition to ethics considerations, the USPTO guidance reminds us that knowing or willful withholding of information about AI use under (A), overlooking AI’s misstatements leading to false certification under (B), or AI-mediated improper or unauthorized exporting of data or unauthorized access to data under (D) and (E) may lead to criminal or civil liability under federal law or penalties or sanctions by the USPTO.

On the positive side, the USPTO guidance describes the possible favorable aspects of AI “to expand access to our innovation ecosystem and lower costs for parties and practitioners…. The USPTO continues to be actively involved in the development of domestic and international measures to address AI considerations at the intersection of innovation, creativity, and intellectual property.” We expect more USPTO AI guidance to be forthcoming, so please do watch for continued updates in this area.

USCIS Announces Information on EB-5 Regional Center Audits

U.S. Citizenship and Immigration Services (USCIS) has announced new provisions regarding EB-5 regional center audits in accordance with the EB-5 Reform and Integrity Act of 2022. Each designated regional center will be audited at least once every five years, and audits will review documentation required to be maintained by the regional center and the flow of immigrant investor capital into capital investment projects. Audits aim to enhance the integrity of the EB-5 program by verifying information in regional center applications, annual certifications, and associated investor petitions.

During site visits for audits, if a regional center representative refuses to participate, the visit will be canceled and the audit report will be completed using available data, noting the cancellation at the request of the regional center. Regional centers that refuse consent or obstruct audits may have their designation terminated.

However, there are generally no immediate adverse consequences for EB-5 associated entities or petitioners solely based on a negative audit result, except in cases of deliberate noncompliance or obstruction. The findings may be used to evaluate a regional center’s eligibility to remain designated and compliance with applicable requirements.

Starting April 23, 2024, audits will adhere to Generally Accepted Government Auditing Standards to ensure uniformity. USCIS launched a new EB-5 Regional Center Audits webpage to provide information on the auditing process.